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Inion OTPS™ BioRestore
EUDAMEDFDA UDIClass III (EU MDR)
Ref BRS-1600
by Inion Oy
Identity
- Trade Name
- Inion OTPS™ BioRestore EUDAMEDInion OTPS BioRestore™ FDA UDI
- Generic Name
- Synthetic bone graft FDA UDI
- Device Name
- Inion BioRestore EUDAMEDBlock 30 x 20 x 8 mm FDA UDI
- Model / Reference
- BRS-1600 EUDAMED1 FDA UDI
- Description
- Block 30 x 20 x 8 mm FDA UDI
Identifiers
- Catalog Number
- BRS-1600 FDA UDI
- Primary DI / UDI-DI
- 06438408007941 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438408007941 EUDAMED
- FDA Product Code
- LYC FDA UDIMQV FDA UDI
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
- GMDN Term
- Synthetic bone graft FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3930 FDA UDI888.3045 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Inion OTPS™ BioRestore by Inion Oy — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06438408007941 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Inion Oy
- EUDAMED SRN
- FI-MF-000000646
Sources (2)
- EUDAMED b3d3f7a3-e516-43e2-8558-e87001bc02ac 61 fields · synced Jul 20, 2026
- FDA UDI 810b19bc-5d33-47c5-a56f-bc94bf3b6816 35 fields · synced May 30, 2026